Deciphering FDA and Menthol

Published August 5, 2013

A few weeks ago, you may have seen some press about an “Advance Notice of Proposed Rulemaking” from the Food and Drug Administration regarding menthol cigarettes. In government-speak, this means that the FDA intends to regulate menthol additives in cigarettes and is giving the public a chance to chime in.

You may have also noticed that the response from ASH and other public health groups was lukewarm at best. Shouldn’t we be ecstatic that the government is moving to regulate a chemical additive that makes smoking more prevalent?

First, let’s review why menthol is a problem:

Menthol makes smoking feel less harsh, making it far easier for children to try it enough times to kickstart an addiction.

Some research indicates that menthol actually increases the addictiveness of nicotine, making it even harder to quit.

The FDA was given the authority to ban menthol outright under the 2009 Act, but has so far failed to do so. In fact, the timing of the announcement last week was not really about public health at all. It was about losing a trade dispute with Indonesia. You can read ASH’s press release on the topic here . In fact, the United States Trade Representative read out the FDA announcement almost verbatim in Geneva at the same time it was released in Washington.

So four years after the FDA had the authority to do something about menthol, and after definitive research on its harms has been concluded, why did it take a trade dispute to finally move the ball forward? We don’t know the answer, but we’re pretty sure the problem is not with the FDA. At both FDA headquarters and the Center for Tobacco Products, there are a number of public health champions, including several who have dedicated their careers to combating tobacco.

We suspect that there is tremendous pressure coming from Congress, which still takes millions of dollars in contributions from the tobacco industry each election (see how much here) and many of whose members unashamedly defend the industry’s interests. Congress can’t control what the FDA does, but it does control how much funding the agency gets, and it can use this “power of the purse strings” to get its way.

You may notice that the FDA announcement doesn’t even call for a ban on menthol. Many insiders have already predicted that the end result of the rulemaking will not be an outright ban, but a limit on the amount of allowable menthol or further restrictions on advertising.

This story is far from over. Send us any questions on clarifications and stay tuned!